Serial monitoring of ovarian cancer risk in women with adnexal mass.

person Todd C. Pappas Aspira Women's Health, Bee Cave, TX info_outline Todd C. Pappas, Srinka Ghosh, Gerard P. Reilly, Ryan Phan

Authors person Todd C. Pappas Aspira Women's Health, Bee Cave, TX info_outline Todd C. Pappas, Srinka Ghosh, Gerard P. Reilly, Ryan Phan Organizations Aspira Women's Health, Bee Cave, TX, Aspira Women's Health, Austin, TX, Axia Women's Health, Cincinnati, OH Abstract Disclosures Research Funding Other Aspira Women's Health Background: Monitoring of ovarian malignancy risk in indeterminate masses is typically done using TVUS and other clinical factors. No biomarkers are available to assist physicians in clinical management of benign or indeterminate adnexal mass either on initial visit or in follow-up. We recently characterized the clinical performance of a deep neural network-derived multivariate index assay (MIA3G) [1] to assess ovarian malignancy risk in retrospective and prospectively collected multi-site clinical studies. Here we present data on MIA3G serial follow-up to monitor ovarian cancer risk in women presented with adnexal mass from the prospective studies. Methods: Data are presented from ongoing multisite clinical studies in which total 924 patients presented with adnexal masses were enrolled. Follow-up visits, scheduled at clinician’s discretion, may have included imaging and blood collection. Specimens were processed for serum and run on a clinical analyzer. MIA3G score from 0-10 was calculated using seven serum biomarkers coupling with patient age and menopausal status based on previously published neural network-based algorithm. MIA3G with NPV of 99.7% (CI:99.2–99.9) was used to risk stratify the patient with an adnexal mass into low probability of malignancy or indeterminate with a validated cut off at 5.0. For this analysis, MIA3G scores were binned into the following Zones: I (0-2.49), II (2.50 -4.99) and II (5.00-10.00). Results: Of 924 enrolled patients, 538 patients had completed clinical and biomarker data on initial study draw. Of these, 145 had at least one follow-up test and 31 had at least two follow-up test. Median duration to first follow-up test was 108 d (~3.6 mon), and median duration to second follow-up test was 272 d (~9.1 mon). Follow-up in 3 MIA3G score zones at the 0 -3.6 and 3.6 - 9.1 mon interval consistently showed 88% patients within zone I remained unchanged, whereas 12% of patients moved to zones II and III. In the 0 - 3.6 mon interval, the median change in MIA3G score from I to II was 2.25 (n = 9, range 0.54 - 3.52) and from I to III was 5.92 (n = 8, range 5.08-7.62 ). In the 3.6 - 9.1 mon testing interval, the median change in MIA3G score from zone I to II was 3.11 (n = 2, range 2.75 to 3.46) and the single patient change from I to III was 6.89. Across both testing intervals, 17%-50% of patients in zone II remain unchanged while approximately 25% patients had score increase to zone III. Importantly, 50% of patients in zone III remained unchanged in the absence of clinical intervention whereas 50% had MIA3G score reduction in association with clinical management. Conclusions: These results indicate that i) the serial follow-up with MIA3G is recommended to monitor the clinical status of the adnexal mass every 3 months, ii) MIA3G score changes of > 2.25 suggest clinical follow-up, and finally iii) the MIA3G is a suitable tool for the effectiveness of clinical management of adnexal mass. [1]: DOI 10.3389/fmed.2023.1102437.